[Congressional Record (Bound Edition), Volume 148 (2002), Part 14]
[Extensions of Remarks]
[Page 19663]
[From the U.S. Government Publishing Office, www.gpo.gov]




         MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002

                                 ______
                                 

                               speech of

                            HON. GENE GREEN

                                of texas

                    in the house of representatives

                        Monday, October 7, 2002

  Mr. GREEN of Texas. Mr. Speaker, I rise today to express my support 
for H.R. 3580, the Medical Device Amendments.
  This bill represents the kind of good public policy that can be 
developed when the parties work together in a bipartisan fashion.
  H.R. 3580 makes a number of important changes to the processes at the 
Food and Drug Administration (FDA) to ensure that life-saving medical 
devices are sped to the market, while at the same time ensuring that 
patient safety is protected. By instituting a system of user fees, this 
legislation will direct an additional $25 to $30 million to the FDA so 
that they can streamline their device approval process.
  The legislation also makes sure that Congress upholds its end of the 
bargain by requiring an additional $15 million to be added to FDA's 
baseline through the appropriations process. As a result, FDA will have 
$40-50 million more over the next five years.
  Additionally, by providing the FDA some flexibility in allowing third 
parties to perform biennial FDA quality systems regulations 
inspections, the agency will be able to clear the backlog, in 
inspections, and ensure that the facilities where these devices are 
made meet the same FDA standard that has been the benchmark.
  This legislation contains important provisions which help clarify 
whether a product designed for single-use has been reprocessed, and 
improves labeling so that individuals and health care providers know 
when a product has been reprocessed.
  However, I am most pleased that this legislation contains provisions 
that would improve our understanding of the long term health 
implications of breast implants. Current data regarding the health 
implications of breast implants fails to answer many questions, 
especially about the longterm health effects of breast implants, their 
effect on the auto-immune system, on neurological function, and on the 
children of women who have them. There is also a gaping void in our 
understanding of how implants affect breast cancer survivors.
  We have also heard from many women that they were not adequately 
informed of the risks associated with implants before their surgeries. 
We have worked very closely with the committee to get some of these 
concerns addressed, and I am pleased that they agreed to include our 
proposal to have the NIH do a study on the long-term health 
consequences of breast implants.
  This study would require NIH to delve into areas that have not been 
previously studied, so that we can have a full understanding of how 
breast implants affect women.
  We were also able to agree on a GAO report, which will study the 
FDA's current informed consent procedures, to evaluate whether women 
are receiving the information they need to make an informed decision, 
whether that information is up-to-date, comprehensive, fair and 
balanced, and understandable. This GAO study will give us the hard data 
we need to determine whether changes to the FDA's process are necessary 
and appropriate.
  I would like to thank Congressman Roy Blunt for his hard work on this 
issue. Roy and I have been working together on this issue for several 
years because we both have constituents who have experienced problems 
with breast implants. We have both heard first hand of the deficiencies 
in our current knowledge base on the effects of implants, as well as 
concerns about the ability of women to receive comprehensive, fair and 
balanced information about the risks of implants.
  I would like to thank Chairman Tauzin and his staff for working so 
closely with us on this issue. A lot of effort went into this entire 
bill--including these provisions--and it would not have occurred 
without his leadership.
  I would also like to thank Dr. Ganske. I know that, as a plastic 
surgeon, he had some concerns about what we were trying to do, but I 
think we were able to work out a reasonable compromise on these issues, 
and that the women he treats will be better served as a result. I think 
that is something we can all be proud of.
  Once again, Mr. Speaker, I voice my support for this legislation and 
urge its passage.

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